Trial Outcomes & Findings for Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model (NCT NCT03634397)

NCT ID: NCT03634397

Last Updated: 2025-09-12

Results Overview

Measure of unimanual arm performance in a wide range of hand functions required for activities of daily living. The test includes 7 timed (seconds) activities (possible 0-120 seconds each); the analysis excludes the writing component, therefore it includes 6 of the 7 original JTHFT components. Faster performance yields lower scores (time). There were 2 baseline tests (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score as the starting value and do not include the first baseline scores.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)
• Results posted on: 2025-09-12

Participant Flow

Participant milestones

Measure	Ipsilesional Arm Training (Experimental Condition) Intervention condition includes therapy of the less-impaired (ipsilesional) arm. Ipsilesional (Less-Impaired) Arm Training: Participants receive virtual reality and manipulation training in their less impaired arm.	Contralesional Arm (Comparison Condition) Comparison control condition includes therapy of the paretic (contralesional) arm. Contralesional Arm Comparison: Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke, for the same duration as the experimental ipsilesional arm training condition.
Overall Study STARTED	29	29
Overall Study COMPLETED	25	28
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model

Baseline characteristics by cohort

Measure	Ipsilesional Arm Training (Experimental Condition) n=29 Participants Intervention condition includes therapy of the less-impaired ipsilesional arm. Ipsilesional Arm Training: Participants receive virtual reality and manipulation training in their less impaired arm.	Contralesional Arm (Comparison Condition) n=29 Participants Comparison control condition includes therapy of the paretic (contralesional) arm. Contralesional Arm Comparison: Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=93 Participants	20 Participants n=4 Participants	41 Participants n=27 Participants
Age, Categorical >=65 years	8 Participants n=93 Participants	9 Participants n=4 Participants	17 Participants n=27 Participants
Age, Continuous	58 years n=93 Participants	59 years n=4 Participants	59 years n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	9 Participants n=4 Participants	18 Participants n=27 Participants
Sex: Female, Male Male	20 Participants n=93 Participants	20 Participants n=4 Participants	40 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) White	23 Participants n=93 Participants	23 Participants n=4 Participants	46 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	29 participants n=93 Participants	29 participants n=4 Participants	58 participants n=27 Participants
Jebsen-Taylor Hand Function Test	29 Participants n=93 Participants	29 Participants n=4 Participants	58 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

Population: 5 participants were randomized, but did not complete intervention due to Covid epidemic, and thus did not have JTHFT at post test 1.

Measure of unimanual arm performance in a wide range of hand functions required for activities of daily living. The test includes 7 timed (seconds) activities (possible 0-120 seconds each); the analysis excludes the writing component, therefore it includes 6 of the 7 original JTHFT components. Faster performance yields lower scores (time).

There were 2 baseline tests (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score as the starting value and do not include the first baseline scores.

Outcome measures

Measure	Ipsilesional Arm Training (Experimental Condition) n=25 Participants Intervention condition includes therapy of the less-impaired ipsilesional arm. Ipsilesional Arm Training: Participants receive virtual reality and manipulation training in their less impaired arm.	Contralesional Arm (Comparison Condition) n=28 Participants Comparison control condition includes therapy of the paretic (contralesional) arm. Contralesional Arm Comparison: Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.
Change in Jebsen-Taylor Hand Function Test (JTHFT) Times From Baseline 2 to Post Test 1	5.07 seconds Standard Error .93	-.11 seconds Standard Error 1.37

PRIMARY outcome

Timeframe: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

Population: All participants with baseline 2 and post test 1 data were included in analysis. Scores are transformed to logit scores. The items ranged on the interval scale from -2.18 to 1.72 log-odds units, called 'logits', with higher logit values indicating more difficult activities. Deltas of logits from baseline 2 to post test 1 are reported.

Participant reported outcome of difficulty of upper extremity based activities. Scores are transformed to logit scores. The items ranged on the interval scale from -2.18 to 1.72 log-odds units, called 'logits', with higher logit values indicating more difficult activities. Deltas of logits from baseline 2 to post test 1 are reported. There were two baseline assessments (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score (when participants were randomized) as the starting value and do not include the first baseline scores. Results do not include covariates.

Outcome measures

Measure	Ipsilesional Arm Training (Experimental Condition) n=25 Participants Intervention condition includes therapy of the less-impaired ipsilesional arm. Ipsilesional Arm Training: Participants receive virtual reality and manipulation training in their less impaired arm.	Contralesional Arm (Comparison Condition) n=28 Participants Comparison control condition includes therapy of the paretic (contralesional) arm. Contralesional Arm Comparison: Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.
Change in Abilhand Scores From Baseline 2 (Prior to Treatment) to Post Test 1	-2.08 score on a scale Standard Error 1.43	-.57 score on a scale Standard Error 1.18

PRIMARY outcome

Timeframe: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

Population: Only participants with baseline 2 and post test 1 are included in analysis. Delta values from baseline 2 to post test 1 are reported and adjusted for age, sex, and hemisphere of lesion.

Measure of functional independence in self care activities scored from 0-100 with higher scores indicating more functional independence. There were two baseline assessments (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score (when participants were randomized) as the starting value and do not include the first baseline scores.

Outcome measures

Measure	Ipsilesional Arm Training (Experimental Condition) n=25 Participants Intervention condition includes therapy of the less-impaired ipsilesional arm. Ipsilesional Arm Training: Participants receive virtual reality and manipulation training in their less impaired arm.	Contralesional Arm (Comparison Condition) n=28 Participants Comparison control condition includes therapy of the paretic (contralesional) arm. Contralesional Arm Comparison: Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.
Change of Score on Barthel Index From Baseline 2 (Prior to Training) to Post Test 1	-1.2 score on a scale Standard Error 1.83	-1.79 score on a scale Standard Error 1.24

PRIMARY outcome

Timeframe: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

Population: Only participants with data at baseline 2 and post test 1 are included in analysis.

Upper-Extremity Measure of paretic arm impairment out of 66 possible points with higher scores indicating more movement, and 0 indicating no functional movement in the arm. There were two baseline assessments (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score (when participants were randomized) as the starting value and do not include the first baseline scores.

Outcome measures

Measure	Ipsilesional Arm Training (Experimental Condition) n=25 Participants Intervention condition includes therapy of the less-impaired ipsilesional arm. Ipsilesional Arm Training: Participants receive virtual reality and manipulation training in their less impaired arm.	Contralesional Arm (Comparison Condition) n=28 Participants Comparison control condition includes therapy of the paretic (contralesional) arm. Contralesional Arm Comparison: Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.
Change in Upper-Extremity Fugl-Meyer Assessment (FM) Score From Baseline 2 (Prior to Training) to Post Test 1	-.68 score on a scale Standard Error .8	-1.61 score on a scale Standard Error .93

SECONDARY outcome

Timeframe: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

Population: All participants with baseline 2 and post test 1 data were analyzed (N=53). 5 randomized participants were excluded from analysis because they did not have baseline 2 and post test 1 measures due to Covid disruption.

Each item on the FIM is scored on a 7-point Likert scale, and the score indicates the amount of assistance required to perform each item (1 = total assistance in all areas, 7 = total independence in all areas). Analysis includes 6 sub-components of the FIM, which are the self care components (Eating, Grooming, Bathing, Dressing upper body, Dressing lower body, and toileting) (possible 42 points). Higher scores indicate more independence.

There were two baseline tests (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score as the starting value and do not include the first baseline scores.

Outcome measures

Measure	Ipsilesional Arm Training (Experimental Condition) n=25 Participants Intervention condition includes therapy of the less-impaired ipsilesional arm. Ipsilesional Arm Training: Participants receive virtual reality and manipulation training in their less impaired arm.	Contralesional Arm (Comparison Condition) n=28 Participants Comparison control condition includes therapy of the paretic (contralesional) arm. Contralesional Arm Comparison: Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.
Change From Baseline 2 (Prior to Training) to Post Test 1on Functional Independence Measure (FIM) -Self Care Components	-1.44 score on a scale Standard Error .75	-.46 score on a scale Standard Error .81

SECONDARY outcome

Timeframe: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

Population: Participants were excluded from this analysis if they could not complete the kinematics for any reason (i.e.: Covid, a pacemaker, not fitting in the kinematic setup), or did not complete both baseline and post test 1 kinematic assessments.

Workspace area is a kinematic measure of active range of motion, which we measured on the paretic (contralesional) arm. This was calculated by computing the area of the ellipse (measured in centimeters) formed by the major and minor axis of the contralesional arm trajectory on each trial. The major axis was defined as the largest distance between any two points in the handpath, while the minor axis was defined as the largest distance, perpendicular to the major axis. Values were averaged within subjects over all trials for each evaluation (i.e. BL2 and PT1), then group and evaluation averages and standard deviations were calculated from these values.

There were two baseline tests (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score as the starting value and do not include the first baseline scores. These values do not include covariates.

Outcome measures

Measure	Ipsilesional Arm Training (Experimental Condition) n=21 Participants Intervention condition includes therapy of the less-impaired ipsilesional arm. Ipsilesional Arm Training: Participants receive virtual reality and manipulation training in their less impaired arm.	Contralesional Arm (Comparison Condition) n=26 Participants Comparison control condition includes therapy of the paretic (contralesional) arm. Contralesional Arm Comparison: Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.
Change From Baseline 2 (Prior to Training) to Post Test 1 on Contralesional Work Space Area (Kinematics)	0.512 centimeters Standard Deviation 2.1217	0.340 centimeters Standard Deviation 1.6714

SECONDARY outcome

Timeframe: Baseline 2 to Post Test 1 (up to 2 weeks post last treatment session)

Population: Participants were excluded if they could not complete the kinematic portion of the study due to Covid, or a pacemaker, or not fitting in the kinematic setup, or if they didn't complete both baseline and post test 1 assessments.

Positional variability is a measure of kinematic variability in reaching movement. This was measured at the participants max reaching velocity and their end position. This was calculated by taking the distance (cm) from the fingertips location at peak velocity/end position on a given trial from its mean location at peak velocity/end position across all trials, for each target. Values were averaged within subjects over all trials for each evaluation (i.e. BL2 and PT1), then group and evaluation averages and standard deviations were calculated from these values.

There were two baseline tests (3 weeks apart) to show unchanged performance in assessments prior to training. Training included 15 sessions over the course of up to 7 weeks. Results reported used the second baseline score as the starting value and do not include the first baseline scores or covariates.

Outcome measures

Measure	Ipsilesional Arm Training (Experimental Condition) n=21 Participants Intervention condition includes therapy of the less-impaired ipsilesional arm. Ipsilesional Arm Training: Participants receive virtual reality and manipulation training in their less impaired arm.	Contralesional Arm (Comparison Condition) n=26 Participants Comparison control condition includes therapy of the paretic (contralesional) arm. Contralesional Arm Comparison: Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.
Change in Kinematics- Positional Variability at Maximum Velocity From Baseline 2 (Prior to Training) to Post Test 1 Maximum Velocity	0.0930727 Centimeters Standard Deviation 0.4369149	-0.0225708 Centimeters Standard Deviation 0.4979299
Change in Kinematics- Positional Variability at Maximum Velocity From Baseline 2 (Prior to Training) to Post Test 1 End Position	0.2811583 Centimeters Standard Deviation 0.5066384	-0.1156399 Centimeters Standard Deviation 1.1076122

Adverse Events

Ipsilesional Arm Training (Experimental Condition)

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Contralesional Arm (Comparison Condition)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ipsilesional Arm Training (Experimental Condition) n=29 participants at risk Intervention condition includes therapy of the less-impaired ipsilesional arm. Ipsilesional Arm Training: Participants receive virtual reality and manipulation training in their less impaired arm.	Contralesional Arm (Comparison Condition) n=29 participants at risk Comparison control condition includes therapy of the paretic (contralesional) arm. Contralesional Arm Comparison: Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.
General disorders Pain resulting in hospitalization	3.4% 1/29 • Number of events 1 • Over the course of the study, up to 12 months following study enrollment.	0.00% 0/29 • Over the course of the study, up to 12 months following study enrollment.
General disorders Fall with knee injury	0.00% 0/29 • Over the course of the study, up to 12 months following study enrollment.	3.4% 1/29 • Number of events 1 • Over the course of the study, up to 12 months following study enrollment.
General disorders Hit head (outside of the intervention period)	3.4% 1/29 • Number of events 1 • Over the course of the study, up to 12 months following study enrollment.	0.00% 0/29 • Over the course of the study, up to 12 months following study enrollment.

Other adverse events

Measure	Ipsilesional Arm Training (Experimental Condition) n=29 participants at risk Intervention condition includes therapy of the less-impaired ipsilesional arm. Ipsilesional Arm Training: Participants receive virtual reality and manipulation training in their less impaired arm.	Contralesional Arm (Comparison Condition) n=29 participants at risk Comparison control condition includes therapy of the paretic (contralesional) arm. Contralesional Arm Comparison: Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.
General disorders back pain	0.00% 0/29 • Over the course of the study, up to 12 months following study enrollment.	3.4% 1/29 • Number of events 1 • Over the course of the study, up to 12 months following study enrollment.
Renal and urinary disorders kidney stone	3.4% 1/29 • Number of events 1 • Over the course of the study, up to 12 months following study enrollment.	0.00% 0/29 • Over the course of the study, up to 12 months following study enrollment.
Psychiatric disorders chronic depressive symptoms	0.00% 0/29 • Over the course of the study, up to 12 months following study enrollment.	6.9% 2/29 • Number of events 2 • Over the course of the study, up to 12 months following study enrollment.
General disorders fall with no fracture	0.00% 0/29 • Over the course of the study, up to 12 months following study enrollment.	3.4% 1/29 • Number of events 1 • Over the course of the study, up to 12 months following study enrollment.
Skin and subcutaneous tissue disorders benign growth	3.4% 1/29 • Number of events 1 • Over the course of the study, up to 12 months following study enrollment.	0.00% 0/29 • Over the course of the study, up to 12 months following study enrollment.

Additional Information

Dr Candice Maenza

Penn State College of Medicine

Phone: 7175310003

Email: cmaenza@pennstatehealth.psu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place